title: Bleeding complications with Drotrecogin alfa activated (Xigris): a retrospective review of 31 operative and 68 non-operative patients with severe sepsis.
abstract: We reviewed 100 consecutive patients who received Drotrecogin alfa (activated) (DAA) (Xigris, Eli Lilly, Indianapolis, IN) for the treatment of severe sepsis and compared the incidence of bleeding complications in surgical (n = 30) and nonsurgical cohorts (n = 70). Thirty patients who received DAA therapy for severe sepsis underwent one or more contemporaneous surgical procedures. These were compared with 70 DAA patients who did not undergo surgery. During the course of DAA administration, transfusion of greater than three units of blood, an intracranial hemorrhage, or other bleeding serious adverse event were qualified as bleeding complications. Overall, we identified seven patients who fulfilled the designated bleeding complication criteria, four in the surgical cohort, and three in the nonsurgical cohort. There was no significant difference in the rate of bleeding complications between surgical and nonsurgical cohorts (P = 0.1063). Moreover, there were no mortalities ascribed to bleeding and there were no intracranial hemorrhage events. All bleeding complications were due to a drop in hemoglobin or platelets only, and were treated with transfusion. Our experience demonstrates that there is an equivalent risk of bleeding for surgical patients treated with DAA compared with nonsurgical patients. Additionally, all bleeding complications were amenable to simple transfusion.
authors.affiliation: Department of Surgery, Santa Barbara Cottage Hospital, Santa Barbara, California 93105, USA. btaylor@sbch.org
authors.forename: Benedict J W
authors.initials: BJ
authors.lastname: Taylor
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Lee
authors.forename: Kenneth
authors.initials: K
authors.lastname: Waxman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use; D005343:Fibrinolytic Agents; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D011379:Prognosis; D011486:Protein C / Q000009:adverse effects* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D018805:Sepsis / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D000890:Anti-Infective Agents; D005343:Fibrinolytic Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated